Try the modernized ClinicalTrials.gov beta website. Learn more about the modernization effort.
Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

Remote Monitoring in Patients With Heart Failure (REM-HF)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04537104
Recruitment Status : Recruiting
First Posted : September 3, 2020
Last Update Posted : January 14, 2021
Sponsor:
Collaborator:
Coala Life, Inc
Information provided by (Responsible Party):
Morten Lamberts, Herlev and Gentofte Hospital

Study Description
Go to 
Top of Page Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information
Brief Summary:
This study is a prospective cohort study with consecutive enrollment of newly diagnosed heart failure patients, investigating the prevalence and types of arrhythmias in this high-risk population using non-invasive remote monitoring with the Coala Heart Monitor. Participants are scheduled to use the Coala Heart Monitor twice daily or during symptoms (e.g. syncope, presyncope, palpitations, chest discomfort, or shortness of breath) to record a thumb and chest ECG over 3 months. Patient compliance with the recordings, self-reported health, response to technology, and experience using the device will additionally be assessed by self-developed questionnaires and the Kansas City Cardiomyopathy Questionnaire (KCCQ) at 3 months.

Condition or disease Intervention/treatment
Heart Failure Device: Coala Heart Monitor

Study Design
Go to 
Top of Page Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

Layout table for study information
Study Type : Observational
Estimated Enrollment : 130 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Investigating Arrhythmias in a High-risk Population With Heart Failure Using Remote Monitoring (Coala Heart Monitor)
Actual Study Start Date : September 24, 2020
Estimated Primary Completion Date : September 1, 2021
Estimated Study Completion Date : September 1, 2023

Resource links provided by the National Library of Medicine


Groups and Cohorts
Go to 
Top of Page Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

Intervention Details:
  • Device: Coala Heart Monitor
    ECG monitoring

Outcome Measures
Go to 
Top of Page Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

Primary Outcome Measures :
  1. New-onset arrhythmias [ Time Frame: 3 months ]
    Incidence of newly diagnosed atrial fibrillation/atrial arrhythmias on patient-activated thumb and chest ECG recordings


Secondary Outcome Measures :
  1. Patient compliance [ Time Frame: Week 8 ]
    Patient compliance with at least two daily recordings.

  2. Patient self-reported health [ Time Frame: 3 months ]
    Patient self-reported health assessed by KCCQ.

  3. Patient-reported outcomes [ Time Frame: 3 months ]
    Patients' response to technology and experience using the device assessed by self-developed questionnaire.

  4. Assessing recordings [ Time Frame: 3 months ]
    Where there are interpretations of arrhythmias on recordings, agreement of recordings with subsequent Holter monitoring will be assessed.

  5. Subsequent prescriptions [ Time Frame: 3 years ]
    Through linkage with nationwide health care databases, subsequent prescription patterns of diuretics and antithrombotic medication in patients with and without atrial fibrillation.

  6. Subsequent implantations [ Time Frame: 3 years ]
    Through linkage with nationwide health care databases, subsequent implantation of cardiac devices in patients with and without atrial fibrillation.

  7. Subsequent readmissions [ Time Frame: 3 years ]
    Through linkage with nationwide health care databases, subsequent readmissions to hospital in patients with and without atrial fibrillation.

  8. All-cause mortality [ Time Frame: 3 years ]
    Through linkage with nationwide health care databases, all-cause mortality in patients with and without atrial fibrillation.

  9. Cardiovascular mortality [ Time Frame: 3 years ]
    Through linkage with nationwide health care databases, cardiovascular mortality in patients with and without atrial fibrillation.

  10. Admissions for worsening heart failure [ Time Frame: 3 years ]
    Through linkage with nationwide health care databases, and admission for worsening heart failure in patients with and without atrial fibrillation.


Eligibility Criteria
Go to 
Top of Page Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Newly diagnosed heart failure patients > 18 years of age from heart failure clinic
Criteria

Inclusion Criteria:

  • Owns or has access to a smartphone
  • Newly diagnosed moderate to severe heart failure (NYHA II-IV and left ventricular ejection fraction ≤ 40%)

Exclusion Criteria:

  • Earlier atrial fibrillation/atrial flutter with indication for oral anticoagulant (OAC) treatment
  • Pacemaker
  • Cardiac resynchronization device
  • Indications for OAC treatment (also low molecular weight heparin) due to atrial arrhythmias, mechanical heart valve, deep vein thrombosis, or pulmonary embolism.
  • Expected survival ≤ 6 months
  • Absolute contraindications for starting OAC treatment
Contacts and Locations
Go to 
Top of Page Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04537104


Contacts
Layout table for location contacts
Contact: Morten Kjøbek Lamberts, MD, PhD +4522434186 morten.kjoebek.lamberts@regionh.dk

Locations
Layout table for location information
Denmark
Department of Cardiology, Herlev & Gentofte Hospital Recruiting
Copenhagen, Hellerup, Denmark, 2900
Contact: Morten Kjøbæk Lamberts, MD, PhD         
Sponsors and Collaborators
Herlev and Gentofte Hospital
Coala Life, Inc
More Information
Go to 
Top of Page Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information
Layout table for additonal information
Responsible Party: Morten Lamberts, Associate Professor and Research Director, Herlev and Gentofte Hospital
ClinicalTrials.gov Identifier: NCT04537104    
Other Study ID Numbers: P-2020-551
First Posted: September 3, 2020    Key Record Dates
Last Update Posted: January 14, 2021
Last Verified: January 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

Layout table for additional information
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: Yes
Product Manufactured in and Exported from the U.S.: No
Keywords provided by Morten Lamberts, Herlev and Gentofte Hospital:
arrhythmias
heart failure
remote monitoring
Additional relevant MeSH terms:
Layout table for MeSH terms
Heart Failure
Heart Diseases
Cardiovascular Diseases